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Cue Biopharma Presents New Positive Data from Phase 1 Trials of CUE-101 in Head and Neck Cancer and CUE-102 in Wilms’ Tumor 1 Positive Cancers at SITC 2023

Overall response rate (ORR) of 47% and disease control rate (DCR) of 65% in first line (1L) recurrent/metastatic HNSCC patients treated with CUE-101 and

articleCue Biopharma, Inc.November 3, 20235/company/cue-biopharma/news/cue-biopharma-presents-new-positive-data-from-phase-1-trials-of-cue-101-in-head-and-neck-cancer-and-cue-102-in-wilms-tumor-1-positive-cancers-at-sitc-2023
Cue Biopharma Presents New Positive Data from Phase 1 Trials of CUE-101 in Head and Neck Cancer and CUE-102 in Wilms’ Tumor 1 Positive Cancers at SITC 2023

About this update from Cue Biopharma, Inc.

[{"type":"text","content":"Overall response rate (ORR) of 47% and disease control rate (DCR) of 65% in first line (1L) recurrent/metastatic HNSCC patients treated with CUE-101 and KEYTRUDA® (pembrolizumab) ORR of 56% in patients with low expression of PD-L1 in the tumor Median overall survival (mOS) of 20.8 months in second line (2L) and beyond patients treated with CUE-101 monotherapy, compared to the historic reported survival of approximately eight months observed in patients treated in 2L in the KEYNOTE-040 trial of pembrolizumabNo dose limiting toxicities (DLTs) observed or maximum tolerated dose (MTD) reached to date with CUE-102 at the dose escalation phaseCUE-102 demonstrated a 75%-80% DCR at the 4mg/kg and 2mg/kg doses respectively with two patients demonstrating tumor reductions of -30% and -29% BOSTON, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of T cell engagers to selectively modulate tumor-specific T cells, announced today the presentation of new positive data from its ongoing fully enrolled Phase 1 trials evaluating its lead interleukin-2 (IL-2)-based T cell engager, CUE-101, as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) for patients with recurrent/metastatic HPV+ head and neck squamous cell carcinoma (HNSCC). New clinical data will also be reported from the company’s ongoing Phase 1 trial evaluating its second candidate, CUE-102, for the treatment of Wilms’ Tumor 1 positive (WT1+) recurrent/metastatic cancers. The data will be presented in two posters at the Society for Immunotherapy of Cancer’s 38th Anniversary Annual Meeting (SITC 2023) being held in San Diego, California and virtually November 1-5. “I am pleased to observe the clinical benefit patients are deriving and encouraged by the positive enhancement of data from the CUE-101 clinical trials,” said Christine Chung, M.D., Chair, Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, and a principal investigator participating in the clinical trial. “The notable prolongation in overall survival to over 20 months in monotherapy represents a significant advancement of clinical benefit compared to the current standard of care for this population with advanced and refractory disease. Similarly, the reported enhanced overall response rate to date in combinatio...

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